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Associate Clinical Writer

3 months ago


Rancho Santa Margarita, United States Applied Medical Full time

________________________________________:
Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.

Position Description:
As an Associate Clinical Writer, you will work within the Clinical Affairs team. The Associate Clinical Writer’s primary responsibilities are developing and completing scientific protocols and reports, including, but not limited to, Clinical Evaluations and Post Market Clinical Feedback as part of design validations for medical devices to support product registrations internationally. You will conduct reviews of post-market data, such as complaints and feedback, to incorporate relevant data and analysis into reports.

**Critical Thinking**:
**Writing Skills**:
You will be responsible for conducting thorough literature searches to identify relevant studies, systematic reviews, and meta-analyses that inform your writing. You will also be responsible for creating and maintaining job aids and work instructions for the preparation and maintenance of compliant medical writing deliverables

**Communication**:
You will be responsible to manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables. You will also be expected to collaborate with cross-functional teams to develop new and insightful analytics to collect and analyze clinical data.

**Performance Objectives**:
Within your first 6 months, you will be responsible for learning about our company, contributing to various projects and leading project management initiatives.

During your first 30 days, you will:

- Learn about Applied’s mission and vision and take part in a variety of Applied Learning foundational courses.
- Discuss your goals and expectations with your team leader(s) and read and review all relevant team resources and materials.
- Immerse yourself in team meetings and discussions.

Within 60 days, you will:

- Exhibit a strong technical understanding of the product line(s) and/or projects
- Support team meetings and agendas.
- Take on one or more projects that require low to moderate guidance.

Within 90 days to 1 year, you will:

- Develop interpersonal connections and relationships with others to effectively accomplish project objectives and deliverables.
- Lead moderate to complex projects with mínimal guidance or direction.
- Demonstrate a strong understanding of Applied’s Quality Management System and effectively troubleshoot challenges or obstacles that may affect project timelines.
- Handle a variety of projects on your own.

Position Requirements:
This position requires the following skills and attributes:

- Bachelor’s or Advanced degree in a scientific field (MS, Ph.D., MD, or Pharm. D.)
- Experience in conducting focused literature searches on PubMed, Embase or other similar literature databases
- Data mining and analysis
- Ability to formulate reports and present findings
- Effective written and oral communication skills
- Ability to collaborate in a team environment
- Project management and organizational skills
- Strong familiarity with Microsoft Office

Preferred:
The following skills and attributes are preferred:

- 0-5 years of experience in the medical device/pharmaceutical field or 1+ years of research with professor
- Ability to understand and interpret results of clinical studies, with a strong understanding of statistics
- Experience performing statistical analysis with statistical programs
- Ability to prioritize and manage multiple projects
- Data analytic publication experience or literature author publication experience

**Inside This Business Group**:
The Clinical Affairs team is responsible for generating scientific research and regulatory plans and reports to support clinical performance and safety of Applied Medical’s devices. The documents that our team creates will be used to obtain and maintain regulatory authorization to market our devices in various regions in the world. Our projects are research focused, which includes screening/extracting/analyzing relevant data from various sources (such as medical literature databases and internal company databases). We also collaborate with various teams and departments, such as regulatory affairs, engineering, and clinical development.

**Benefits**:
We understand that compensation is an important aspect of any job, which is why we offer a comprehensive total reward package for this While the base compensation range for this position in California is $70000 - $80000 / year, your actual compensation package will be b